CIPLA GEFITINIB gefitinib 250 mg tablet blister pack

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

gefitinib, Quantity: 250 mg

Tillgänglig från:

Cipla Australia Pty Ltd

Läkemedelsform:

Tablet, film coated

Sammansättning:

Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; povidone; sodium lauryl sulfate; magnesium stearate; lactose monohydrate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350

Administreringssätt:

Oral

Enheter i paketet:

30 tablets

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

Treatment of patients with locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) whose tumours express activating mutations of the EGFR tyrosine kinase.

Produktsammanfattning:

Visual Identification: Round, biconvex, brown film-coated tablets debossed with C on one side and plain on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Bemyndigande status:

Registered

Tillstånd datum:

2020-05-06

Bipacksedel

Cipla Gefitinib
1
CIPLA GEFITINIB
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CIPLA GEFITINIB?
Cipla Gefitinib contains the active ingredient gefitinib. Cipla
Gefitinib is used to treat non‐small cell lung cancer, which is one
type of lung cancer.
For more information, see Section 1. Why am I using Cipla Gefitinib?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIPLA GEFITINIB?
Do not use if you have ever had an allergic reaction to Cipla
Gefitinib or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Cipla Gefitinib? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cipla Gefitinib and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE CIPLA GEFITINIB?
•
The usual adult dose is one 250 mg tablet taken each day.
•
Swallow your Cipla Gefitinib tablet whole with a glass of water. Do
not chew or crush the tablets.
More instructions can be found in Section 4. How do I use Cipla
Gefitinib? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CIPLA GEFITINIB?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Cipla Gefitinib.
•
Be sure to keep all your appointments with your doctor so your
progress can be checked.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not give Cipla Gefitinib to anyone else, even if they have the same
condition as you.
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how Cipla
Gefitinib affects you.
LOOKING AFTER
YOUR MEDICINE
•
Keep it in a cool dry place where the temperature stays

Produktens egenskaper

AUSTRALIAN PRODUCT INFORMATION - CIPLA GEFITINIB (GEFITINIB)
FILM-COATED TABLETS
1.
NAME OF THE MEDICINE
Gefitinib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg of gefitinib.
Description
Gefitinib is a white or almost white, crystalline powder. It has pKas
of 5.42 and 7.24 and
therefore ionises progressively in solution as the pH falls. Gefitinib
can be defined as
sparingly soluble at pH 1, but is practically insoluble in water and
above pH 1. Gefitinib is
achiral.
Excipient(s) with known effect
Each film-coated tablet contains 163.50 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets (tablet).
Tablets are round, biconvex, brown film coated tablets debossed with
‘C’ on one side and
plain on the other side. Diameter: 11.10 mm ± 0.20 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of patients with locally advanced or metastatic Non-Small
Cell Lung Cancer
(NSCLC) whose tumours express activating mutations of the EGFR
tyrosine kinase.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
The recommended dose of Cipla Gefitinib is one 250 mg tablet once a
day, taken with or
without food. If a dose of Cipla Gefitinib is missed, it should be
taken as soon as the patient
remembers. If it is less than 12 hours to the next dose, the patient
should not take the missed
dose. Patients should not take a double dose (two doses at the same
time) to make up for a
forgotten dose.
Method of administration
Where dosing of whole tablets is not possible, such as patients who
are only able to swallow
liquids, tablets may be administered as a dispersion in water. The
tablet should be dropped
into half a glass of drinking water (non-carbonated), without
crushing, and the glass stirred
until the tablet has dispersed (approximately 15 minutes) and the
contents subsequently drunk
2
immediately. The glass should be rinsed with a further half glass of
water and the contents
drunk. The liquid can also be administered via a nas